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FertiPro

Active in EUDAMED

Belgiumfrom SRN EUDAMED FDA SRN BE-MF-000000313

FertiPro is a medical device manufacturer based in Belgium, with 68 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class B, A, IIa and III) as of 14 Nov 2026.

Devices
68
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 67
  • FDA GUDID 40
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class B 26
  • EU Class A 18
  • EU Class IIa 13
  • EU Class III 7
  • EU Class I 3
  • FDA Class II 1
Top EMDN categories
Identifiers
  • EUDAMED SRN BE-MF-000000313

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

What FertiPro makes

FertiPro manufactures diagnostic reagents and media for reproductive health, including sperm staining solutions (Spermac Stain A, B, and C), sperm analysis kits (SpermMar Test IgG and IgA), and culture media for assisted reproductive technology (FertiCult High Viscosity Oil, Sil-Select Plus). The company also produces reagents for sperm vitality and epithelial cell screening (VitalScreen, EpiScreen Plus) and devices for sperm preparation (Floater, Insert).

The portfolio includes devices classified as Class A, B, I, IIa, and III under EU regulations, with all relevant products listed in the EUDAMED database. FertiPro’s products are authorised as either in vitro diagnostics or medical devices, adhering to regulatory frameworks in Europe, Canada, and the United States. The company is headquartered in Belgium.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
BE-MF-000000313
SRN (system / procedure pack)
BE-PR-000000330
EU VAT number
BE0448767035
EUDAMED status
Active
EUDAMED registered name
FertiPro
Registered address
32, industriepark noord, 8730, Beernem, Belgium
Phone
+3250791805
PRRC contact
Ilse Jonckheere(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Fertipro NV US

From the company website

Read 18 Sep 2026

FertiPro is an ISO13485 certified company, that participates in the MDSAP program. FertiPro has product registrations in Europe, Canada, United States of America and in increasingly more countries worldwide. All of the diagnostic kits and ART media are CE marked either as in vitro diagnostics or as medical devices. Certificates of analysis for all products are available upon request.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does FertiPro have in the registry?

The registry currently lists 68 devices for FertiPro. Devices recorded under merged duplicate company entries are counted once.

Which registries list FertiPro's devices?

Among its 50 most recently registered devices, FertiPro has devices listed in EUDAMED (49 devices), FDA 510(k) (1 device) and FDA GUDID (30 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do FertiPro's devices fall under?

Among its 50 most recently registered devices, the classes recorded for FertiPro's devices are Class I, Class IIa, Class II, Class III, IVDR Class A and IVDR Class B. Each device page shows its own class and authorisation.

What are the newest devices from FertiPro in the registry?

The most recently registered devices listed for FertiPro include InActiv Blue, Spermac Stain B - 250 ml, Floater and DRDP.

Which FDA establishments are linked to FertiPro?

1 FDA establishment is linked to FertiPro in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.